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Completed

NCT Number: NCT05689268

EUS-PPG vs HVPG in Portal Hypertension

The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.

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Key information

Conditions

Cirrhosis Digestive System Diseases Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Portal Hypertension

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Endoscopia. Hospital General Universitario de Alicante

Alicante, 03010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years
  • Undergoing evaluation for chronic liver disease or portal hypertension
  • Signed informed consent

Exclusion criteria

  • Uncorrectable coagulopathy (INR above 1.5)
  • Uncorrectable thrombocytopenia (Platelets under 50,000)
  • Anticoagulation or antiplatelet therapy that cannot be discontinued
  • Biliary obstruction
  • Grade II ascites or more
  • Intrahepatic portal vein thrombosis
  • Pregnancy

Treatment and study plan

EUS-PPG and HVPG

Diagnostic Test

EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.

On the same day or on successive days HVPG measurement will be performed.

Primary outcomes

  1. Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.

    Time frame: 1 day

    Portal pressure gradient measurement will be performed by direct echoendoscopy-guided puncture with a 22 G needle of the portal vein and the suprahepatic vein. On the same day or on successive days, hepatic venous pressure gradient determination will be performed by interventional radiology. For this purpose, the free hepatic venous pressure and the wedged pressure will be measured using a balloon catheter and jugular approach, following the usual procedure.

Secondary outcomes

  1. Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.

    Time frame: 1 day

    The percentage of echoendoscopy-guided portal pressure gradient (EUS-PPG) measurements versus the percentage of successful hepatic venous pressure gradient (HVPG) measurements using Chi-square will be compared.

  2. Adverse effects at 30 days after each procedure by clinical follow-up of patients at 24 hours, 7 days, and 30 days using the American Society of Gastrointestinal Endoscopy Severity grading system, from mild to fatal.

    Time frame: 30 days

    Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.

Sponsors and collaborators

Lead sponsor

Hospital General Universitario de Alicante

Other

Registry information

Official study title

EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)

Acronym: GRAPE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2023
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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